A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients with Advanced or Metastatic Breast Cancer

Exclusion Criteria

• - Male
• - life-threatening metastatic visceral disease
• - evidence of clinically active interstitial lung disease
• - ER and PR negative
• - treatment with LHRH analogues < 3 months prior to enrolment
• - patients who have restarted menses or do not have FSH levels within the postmenopausal range
• - treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months
• - Treatment with hormonotherapy and/or chemotherapy for advanced disease
• - extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of bone marrow, e.g. whole of pelvis or half of spine)
• - currently receiving oestrogen replacement therapy
• - treatment with a non-approved or experimental drug within 4 weeks before enrolment
• - absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy
• - any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
• - concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known
• - severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.